The purpose of the proposed contract is to provide regulatory expertise and support to operate and manage the Division of AIDS (DAIDS) Regulatory Support Center (RSC) to provide a wide range of HIV/AIDS clinical research activities and programs for DAIDS. The DAIDS RSC provides comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international HIV clinical trial research; 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the DAIDS Enterprise System (DAIDS-ES) and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.